Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study

Abstract

Introduction Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evaluated the use of OW semaglutide in a real-world patient population with type 2 diabetes (T2D) in the UK. Methods In this prospective, observational study, adults (≥ 18 years) with ≥ 1 documented glycated haemoglobin (HbA 1c ) value ≤ 12 weeks before semaglutide initiation were enrolled. The primary endpoint was change in HbA 1c from baseline to end of study (EOS; ~ 30 weeks, although due to the COVID-19 pandemic, visits up to week 52 were permitted). Secondary endpoints included change in body weight, waist circumference and patient-reported outcomes (PROs). Physicians were to report all episodes of documented or severe hypoglycaemia, fatal events, serious adverse drug reactions, pregnancies and adverse events (AEs) in foetuses/newborn infants; other AEs during the study period could be reported on a voluntary basis. Result The estimated mean change in HbA 1c from baseline to EOS was − 16.3 mmol/mol [95% confidence interval (CI): − 18.22, − 14.37] (− 1.5%-points [95% CI − 1.67, − 1.31]; p < 0.0001) among the 171 enrolled patients who completed the study on treatment. Mean body weight change was − 5.8 kg (95% CI − 6.75, − 4.94; p < 0.0001). Sensitivity analyses showed similar results. Improvements were also observed in other secondary endpoints, including PROs. No new safety concerns were identified with semaglutide treatment. Conclusion Patients receiving OW semaglutide experienced statistically significant and clinically relevant reductions from baseline in HbA 1c and body weight. These results are in line with those of the SUSTAIN RCTs and support the use of OW semaglutide in routine clinical practice in adults with T2D in the UK. Trial registration ClinicalTrials.gov Identifier NCT03876015. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01141-8.

Once-Weekly Semaglutide Use in Patients with Type 2 Diabetes: Results from the SURE Spain Multicentre, Prospective, Observational Study

“…Overall, the results of this study support previously reported data on the real-world use of OW semaglutide in Spain [ 39 , 40 , 41 ]. The reduction in HbA 1c and BW observed in Spain align with those observed in the countries that have published results from the SURE programme to date—Canada, Denmark/Sweden, Switzerland, and the UK—for which the mean change in HbA 1c from baseline to EOS was between −0.8 and −1.5%-points and the mean change in BW from baseline to EOS was between −4.3 and −5.8 kg [ 42 , 43 , 44 , 45 ]. The results are also aligned with real-world evidence from other countries, for example, a study by Marzullo et al, that showed reductions in HbA1c and body weight after 6 and 12 months of OW semaglutide treatment in people with T2D in Italy [ 46 ].…”

Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups

“…The study design and endpoints were similar for all four SURE studies and have been reported elsewhere 21–24. The participating clinics were selected in close collaboration with the Novo Nordisk affiliates in the various countries to ensure representativeness of the local populations.…”

“…The results from the first four individual SURE studies to report (CA (n=452),21 DK/SE (n=331),22 CH (n=214)23 and UK (n=215))24 showed that patients receiving OW semaglutide experienced statistically and clinically significant improvements in glycemic control and reduction in body weight. Because of the impact of the coronavirus (COVID-19) pandemic on the timelines of the incomplete SURE studies, as well as the resultant changes to protocols, it was decided to perform a pooled analysis only of the first four available studies.…”

Effect of once‐weekly semaglutide versus thrice‐daily insulin aspart, both as add‐on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open‐label, multinational, phase 3b trial

“…An imbalance in AEs with fatal outcome was observed with semaglutide versus IAsp, which contrasts with previous, extensive data with OW semaglutide from clinical trials, [13][14][15][16][17][18][19][20][21][22] including the CVOT SUS-TAIN 6 22 and real-world data. [38][39][40][41] There was no clustering of causes or any observed pattern regarding the timing of AEs with fatal outcome (Table S8). Deaths primarily occurred in participants with multiple, longstanding pre-existing medical conditions.…”